Kornimate/medical-research-clean huggingface dataset:
expanded access program with nivolumab in combination with ipilimumab in patients with tumors unable to be removed by surgery or metastatic melanoma

Conditions: Malignant Melanoma

Summary: the purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(ctla)-4 and anti-pd-1 treatment-naive and have unresectable or metastatic melanoma.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * men and women 18 years and older * eastern cooperative oncology group (ecog) performance status of 0-1 * histologically-confirmed unresectable stage iii or stage iv melanoma, as per american joint committee on cancer (ajcc) staging system, including mucosal and ocular melanoma * subjects must be anti-ctla-4 treatment-naive and anti-pd-1 treatment-naive. subjects may have had other prior systemic treatment for localized or metastatic disease * subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (mri) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. there must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration exclusion criteria: * active (symptomatic) and not treated brain metastases or leptomeningeal metastases * life expectancy \< 6 weeks * subjects with active, known, or suspected autoimmune disease. subjects with type i diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll * subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease * subjects who received prior therapy with an anti-ctla-4, anti-pd-1, anti-pd-l1 or anti-pd-l2, anti-ct137 (or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab
the effect of simvastatin on bone remodeling in socket of mandibular teeth

Conditions: Hypercholesterolemia

Summary: simvastatin has been reported to promote osteoblastic activity and inhibit osteoclastic activity by enhancing the expression of bmp2. there have been many studies demonstrating the bone-promoting effect of local application various animal models including after application into socket of teeth in a rat. the purpose of the study is to investigate the effect of slow release topical simvastatin in socket of mandibular teeth on bone remodeling in the socket

after extraction of mandibular single root teeth 10 mg of slow release simvastatin would be inserted to the socket. observation will be at 1 week, 4 weeks and 3 months.after 3 months the patients will have dental ct as done routinely in our clinic before placing dental implants and the bone density and height will be measured on this data. during the procedure of inserting a dental implant a trephine will be taken for histology.

Eligibility criteria:
inclusion criteria: * need extraction of single root tooth * intend to have prosthetic implant in place of extraction exclusion criteria: * treated with simvastatin p.o for hypercholesterolemia

Keywords: simvastatin alveolar bone tooth extraction remodeling alveolar bone remodeling
effectiveness of enhanced mental health support for young people

Conditions: Depression; Anxiety; Emotional Stress

Summary: the aim of the research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents.

in this study, the impact of a short psychological intervention on adolescent emotional well-being, symptoms, and functioning is assessed. the intervention is a short intervention based on the methods of cognitive-behavioral therapy comprising 6 weekly sessions. it is delivered by psychiatric nurses working in the schools in the city of turku. the participants are adolescents aged 12-18 who seek student health care due to mental health problems. the goal is to recruit 150 participants. the intervention is not tied to some particular disorder and thus, the main response variable is emotional well-being. emotional well-being is measured at both the beginning and the end of the intervention, and at 6-month follow-up using the young person's clinical outcomes for routine evaluation (yp-core) questionnaire. effectiveness is measured as a change in the yp-core scores.

Eligibility criteria:
inclusion criteria: * young person's clinical outcomes for routine evaluation (yp-core) score ≥14 * willing and able to commit to the intervention and study protocol * sufficient proficiency in finnish exclusion criteria: * other ongoing mental health treatment * substance use as the main problem

Keywords: depression anxiety intervention adolescents school
a study to characterize regimens of basal insulin intensified with either symlin® or rapid acting insulin in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this will be a randomized, open label, parallel group, multicenter study. there will be two phases in the study. phase 1 (baseline to week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 u total of insulin per day or are candidates for the initiation of insulin therapy. the purpose of phase 2 (week 24 to week 36) is to explore further intensification of diabetes regimens in patients failing to achieve hba1c \<=6.5% at week 24.


Eligibility criteria:
inclusion criteria: * has a clinical diagnosis of type 2 diabetes mellitus * has an hba1c \>7.0% and ≤10.0% * has a bmi of ≥25 kg/m\^2 and ≤50 kg/m\^2 * has been on a regimen of insulin for less than 6 months and is taking less than 50 u total of insulin per day, or has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy exclusion criteria: * has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months * requires the use of drugs that stimulate gastrointestinal motility * has been previously treated with symlin (or has participated in a symlin clinical study) * is currently being treated with any of the following medications: \*over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat \[xenical®\] and sibutramine \[meridia®\]); \*oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; \*drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide \[reglan®\]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; \*investigational medications * has a history or presence of any of the following: \*eating disorders (including anorexia and/or bulimia); \*bariatric surgery (gastric bypass, gastric banding, or gastroplasty) * is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study * has donated blood within 30 days of study start or plans to donate blood during the duration of the study

Keywords: symlin amylin insulin humalog novolog apidra
bleeding profile with continuous hormone replacement therapy of activelle® in postmenopausal women

Conditions: Menopause; Healthy

Summary: this study is conducted in europe. the aim of this study is to investigate the bleeding profile after switch from trisekvens® to activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (neta)).


Eligibility criteria:
inclusion criteria: * healthy women * at least 3 months on trisekvens® before screening period * ability to understand and comply with the protocol requirements exclusion criteria: * less than 12 months or more than 36 months postmenopausal judged by the investigator * known, suspected, or past history of hormone dependent tumor/cancers * deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions * ischemic heart disease or myocardial infarction within 6 months prior to randomization
safety and immunogenicity of a/h1n1-soiv (swine flu) vaccine with and without adjuvant in non-elderly and elderly adults

Conditions: Influenza

Summary: this study will evaluate the safety and immunogenicity of different combinations of a/h1n1 s-oiv (swine flu) vaccine in non-elderly and elderly adults.


Eligibility criteria:
inclusion criteria: * adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months. exclusion criteria: * history of serious disease. * history of serious reaction following administration of vaccine or hypersensitivity to vaccine components. * known or suspected impairment/alteration of immune function. * receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination. * sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study. * for additional entry criteria, please refer to protocol.

Keywords: swine flu flu vaccine adults elderly non-elderly adjuvant
pre-implantation genetic testing for monogenic disease: single center experience

Conditions: Genetic Disease; Aneuploidy

Summary: this monocentric retrospective observational study aims to evaluate the efficacy of pre-implantation genetic testing for monogenic diseases (pgt-m). the effectiveness will be assessed in terms of live birth rate (lbr), cumulative live birth rate (clbr) per couple, and abortion rate (ar). considering how many cycles the participants have undergone to achieve a viable blastocyst. the secondary objective is to evaluate the incidence of aneuploidy in unaffected embryos, in order to understand the need for pre-implantation genetic testing for aneuploidy (pgt-a)in addition to pgt-m.


Eligibility criteria:
inclusion criteria: * patients fertile or infertile that have undergone preimplantation genetic testing for monogenic diseases (pgtm). exclusion criteria: * no exclusion criteria will be taken into consideration.
tcd monitoring technology guides the precise control of blood pressure after evt

Conditions: Acute Ischemic Stroke

Summary: investigators hypothesized that the precise regulation of blood pressure based on the changes of cerebral blood flow parameters under tcd monitoring can better improve the state of cerebral blood flow, reduce the risk of early neurological deterioration and improve the prognosis of the patients.


Eligibility criteria:
inclusion criteria: * 18 years of age or older; * accept evt treatment within 6 hours of symptoms onset; * in selected patients with ais within 6 to 16 hours of last known normal who have lvo in the anterior circulation and meet other dawn or defuse 3 eligibility criteria.. * in selected patients with ais within 6 to 24 hours of last known normal who have lvo in the anterior circulation and meet other dawn eligibility criteria. exclusion criteria: * pre - onset mrs\>2; * severe dementia; * threatening life diseases (such as malignant tumor, etc.); * non acute ischemic cerebrovascular disease patients undergoing selective intravascular treatment; * related sound window closure can not be monitoring with tcd.
clinical results of asqelio trifocal diffractive intraocular lens

Conditions: Cataract

Summary: the study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens asqelio trifocal iol tflio130c in healthy subjects submitted to non-traumatic cataract surgery. this clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.


Eligibility criteria:
inclusion criteria: * patients submitted to cataract surgery and implanted with asqelio trifocal iol tflio130c * patients signing a consent form * patients seeking spectacle-independence following surgery * iol power between +5.00 and +34.00 d * transparent intraocular media, except for the cataract prior to surgery, in both eyes * postoperatory potential visual acuity of 20/25 or better. exclusion criteria: * preoperatory corneal astigmatism greater than 0.75d * patients not providing informed consent * previous corneal surgery or trauma * irregular cornea (i.e. keratoconus) * choroidal hemorrhage * microophthalmos * severe corneal dystrophy * uncontrolled or medically controlled glaucoma * clinically significant macular changes * severe concomitant ocular disease * not age-related cataract * severe optic nerve atrophy * diabetic retinopathy * ambyopia * extremely shallow anterior chamber * severe chronic uveitis * pregnant or lactating * rubella * mature/dense cataract sifficulting preoperative fundus assessment * previous retinal detachment * concurrent participation in other investigation using drugs or clinical devices * expecting ocular surgery within the study period

Keywords: cataract surgery intraocular lens multifocal refractive correction
efficacy study of imatinib mesylate to treat philadelphia-positive acute lymphocytic leukemia

Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

Summary: the objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having philadelphia chromosome positive acute lymphocytic leukemia (all).


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed diagnosis of all. * patients confirmed to be ph chromosome positive or bcr-abl gene positive. * patients in relapse * patients refractory to initial remission induction therapy * patients ineligible for initial remission induction therapy * patients with an ecog performance status score from 0 to 2 * serum creatinine concentration of not more than 2 × the upper limit of the normal range (uln) * ast (sgot) and alt (sgpt) of not more than 3 × uln. in patients with hepatic dysfunction from leukemic involvement, ast (sgot) and alt (sgpt) should be not more than 5 × uln * serum bilirubin level not more than 3 × uln exclusion criteria: * patients with findings indicative of leukemic involvement of the central nervous system * patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder) * patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug * patients having received any hematopoietic stem cell transplantation who have a grade 3 or 4 gvhd. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: ph+all imatinib mesylate
to evaluate the efficacy and safety of multi-parameter non-invasive glucose sensors for for blood glucose measurement

Conditions: Diabetes Mellitus

Summary: this was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes. comparing glucose measurements from the non-invasive glucose monitoring system to venous blood glucose or fingertip blood glucose to evaluate system accuracy capability.

at the same time, blood glucose was measured by non-invasive blood glucose meter, accu-chek guide blood glucose meter and ekf biosen c-line. eight groups of blood glucose values were collected from each subject during fasting, after breakfast and after lunch.after the end of blood glucose measurement, the data were recorded, including adverse events and device defects during the test. the subjects were required to stay in the examination room for 5-10 minutes, during which they completed the product use evaluation questionnaire.

Eligibility criteria:
inclusion criteria: * subjects with diabetes (type 1 or type 2 ); * participants who could understand the purpose of the trial and signed the informed consent form. exclusion criteria: * conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc. * diseases that affect the accuracy of hand measurement, such as parkinson's disease, upper limb chronic arterial occlusive disease, raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc. * fever (axillary temperature \>37.3℃) and severe dehydration during screening; * diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent; * those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc. * those suffering from mental illness, lack of self-control or unable to express their personal willingness clearly; * participants who participated in other drug or device clinical trials within 2 weeks before signing the informed consent (except those who failed in screening); * other persons deemed by the investigator to be ineligible for clinical trial participation.

Keywords: blood glucose self-monitoring non-invasive glucose meter
local injection for the treatment of chronic wounds and pain caused by chronic wounds

Conditions: Pain; Chronic Wound

Summary: chronic wounds are wounds or ulcers that do not heal properly and are generally classified as venous, arterial, diabetic, traumatic and pressure chronic wounds and is often associated with inflammatory and neuropathic pain. preliminary clinical studies have confirmed that injection of freshly prepared ha35 promoted the healing of chronic wounds and relieved the pain associated with chronic wounds. this clinical study is a prospective repeated experiments. the purpose of this study was to verify the effectiveness of ha35 injection therapy.

our previous study, together with other studies, showed that topical use of the tissue-permeable ha fragment ha35 relieves swelling of the skin and mucosal wounds. in this study, the tissue-permeable 35 kda ha fragment ha35 was freshly manufactured by mixing hyaluronidase ph20 injectable solution (h31022111) and high-molecular-weight ha injectable solution (h20174089). the therapeutic effect of the tissue-permeable ha fragment ha35 for the treatment of pain-associated chronic wounds was studied in a single-arm off-label study before and after treatment comparison.

Eligibility criteria:
inclusion criteria: * the chronic wounds of painful diabetic wounds, venous wounds, arterial wounds, traumatic and pressure wounds whichvhad not been closed more than 3 months. * all the chronic wounds were clinically presented by surface darkeness and purulent secretions on the wounds, and darkness or redness, swelling, dryness and broken surface of the skin immediately surrounding the wounds. * subject agrees to be compliant with study related visit and treatment schedule. * written informed consent. * adults aged 18-60 years. exclusion criteria: * have a persistent pain resulted from other medical conditions or unknown causes. * history of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing. * subjects with any known coagulation disorder. * pregnant females. * be concomitantly participating in another clinical study.
study of dry beriberi in mayotte, comoro archipelago

Conditions: Dry Beriberi

Summary: the purpose of this study is to assess the existence of a genetic factor, suspected to be involved, aside from likely food deficiency contribution, in occurrence of dry beriberi, in patients who experienced dry beriberi and in a case group composed of 3 people, free from beriberi, within the same household.

a team of 2 investigators, a nurse and an investigator speaking french, shibushi and shimaore (3 languages in use in mayotte), will visit exposed patients who agreed to participate to the study. 3 controls, fulfilling inclusion criteria, will be recruited within the household by drawing lots. clinical examination and food survey by means of a questionnaire will be performed. blood samples will be drawn to determine thiamine status, vitamin b1 dosage, erythrocyte transketolase activity and thiamine pyrophosphate effect, analysis will be performed by biomnis laboratory in lyon. for the genetic study, 4 drops of blood will be put down on whatman paper and sent to dr johannes coy in darmstadt germany, for dna extraction and pcr screening for mutations.

Eligibility criteria:
inclusion criteria: * patients * native to the comoro archipelago (grande comore, mayotte, anjouan, mohéli) * fulfilling the clinical definition of the dry beriberi. * both sexes. * older than 15 years and 3 months (limit of the paediatrics). * having signed and whose legal representatives signed the form of assent, having understood the information. * benefiting from a social coverage regime. * controls * native to the comoro archipelago. * people living in the same household as the patient, sharing the same meals. * both sexes. * older than 15 years old and 3 months. * free from beriberi. * with normal neurological examination. * having signed and whose legal representatives signed the form of assent, having understood the information. * benefiting from a social coverage regime. exclusion criteria: * aged under 15-year-old and 3 months. * for the patients and the witnesses, the presence of pathologies known to increase needs in vitamin b1 (cancer, infectious diseases, fever, hyperthyroïdism, chronic alcoholism).

Keywords: comoro island vit b1 intake thiamine status genetic factor
study of chemotherapy combined with nimotuzumab in untreated metastatic nasopharyngeal carcinoma

Conditions: Stage IV Nasopharyngeal Carcinoma

Summary: this is an open-label, uncontrolled, multicenter phase ii clinical trial. the purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of nasopharyngeal carcinoma * distance metastasis at least 6 months after radical treatment * not suitable for local treatment, e.g. surgery, tace * at least one measurable lesion * estimate survival \>3months * range from 18～70 years old * ps 0\~1 * wbc count ≥ 4×109/l，hemoglobin ≥ 100g/l， platelet count ≥ 100×109/l * alt or ast \< 2.5×uln、bilirubin \< 1.5×uln * 0serum creatinine \< 1.5×uln exclusion criteria: * central nervous system metastases * suitable for local treatment * second malignancy within 5 years * precious therapy with an investigational agent * uncontrolled seizure disorder or other serious neurologic disease * ≥ grade ш allergic reaction to any drug including in this study * clinically significant cardiac or respiratory disease * creatinine clearance \< 30ml/min * drug or alcohol addition * do not have full capacity for civil acts * severe complication, active infection * concurrent immunotherapy or hormone therapy for other diseases * pregnancy or lactation